Resource4thePeople announced today detailed specifics of the types of consumer claims that are being reviewed involving DePuy Orthopaedics diaphyseal knee sleeves that have been the subject of a U.S. food and Drug Administration Class 1 Recall.*

"In response to the increasing number of questions that we have been receiving from consumers involving allegations of serious side effects detailed in the FDA recall we are spelling out exactly what our experienced product defect lawyers are reviewing," said Resource4thePeople.

"The allegations being reviewed will qualify for our offer of free legal consultations to any consumer who may have been affected by the concerns raised by the FDA and is eligible to seek compensation for any medical or other costs involved as well as pain and suffering.

Resource4thePeople said that the specific issue raised by the FDA and being reviewed by our attorneys was contained in the Feb. 22, 2013 Class 1 Recall under the FDA's "Reason for Recall:"

"The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death."

Resource4thePeople notes that the FDA describes Class I recalls such as those issued for the DePuy knee sleeve as the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death, the FDA said.

"We urge any consumers who have suffered any of the following medical conditions allegedly as a result of an operation involving a DePuy knee sleeve to take advantage of our complimentary consultations," said Resource4thePeople.

Here is a partial list of the conditions being investigated:

Infections

Pain

Possible loss of limb

Decreased range of motion

Lengthening or shortening of leg

Dislocations

Subluxation

Flexion contracture

Bone fractures

Shifts in the positioning of the device

Loosening, bending, cracking, fracture, deformation or wear of one or more of the components

Resource4thePeople also has updated its consumer information resource center in which details of the FDA recall and other important information about allegations involving the DePuy LPS Diaphyseal Knee Sleeve are now posted.

These details also include types of knee sleeve failures, symptoms and other important information for consumers who may have been affected by the concerns raised in the FDA recall, said Resource4thePeople.

"We also are encouraging all consumers considering a knee operation or those who have had a DePuy knee sleeve implanted to completely familiarize themselves with what the FDA considers life-threatening concerns."

In addition to offering free consultations to consumers seeking information about legal options they may have to seek compensation over allegations of injuries from the DePuy Orthopaedics LPS Diaphyseal Knee Sleeve systems Resource4thePeople also will be reviewing similar claims involving DePuy metal-on-metal hip implant systems.

In the recall notice the FDA said it had notified health care professionals of the Class I Recall of the LPS Diaphyseal Sleeve.

The FDA said it had, at the time of the recall, received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.

The FDA said the affected devices were manufactured from 2008 to July 20, 2012.

"Medications and medical devices are constantly under scrutiny from the FDA, which is acting in the interests of consumers and any health concerns, such as a Class 1 recall, should be taken seriously and all consumers should fully inform themselves of the dangers," said Resource4thePeople.

"Our web site is providing an information bank about this recall and those of metal hip implants that were also the subject of a Class 1 FDA recall."

The metal hip implants were the subject of an August, 2010 recall** in which the FDA said it was reviewing reports that one of the DePuy metal-on-metal hip replacement systems was failing at rates of up to 13 percent in patients who had undergone hip operations.

“The fact that two different medical devices from DePuy have been recalled raises serious questions about the quality and safety of these products and our lawyers will now be offering free consultations to consumers who have allegations of serious injuries or health problems attributed to either product,” said Resource4thePeople.

“Even though the hip devices were recalled over three years ago we are still accepting claims from consumers affected by those problems as well as the more recent cases involving the DePuy knee sleeves.

FDA officials warned in their knee sleeve recall that health complications as drastic as death could occur if the device malfunctions.

“The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients,” the FDA said in its warning.

“This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.”

The DePuy Orthopaedics LPS Diaphyseal Knee Sleeve is described by the manufacturer as an end-stage revision knee device used in numerous operations by surgeons reconstructing severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.